Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Vanguard Biomedical Corp. — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

69 daysmedian FDA review time
118 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K960733MINISTICK PREGNANCY TESTVanguard Biomedical Corp.1996-05-01690
K960233MINICLINIC OVULATION PREDICTORVanguard Biomedical Corp.1996-04-23970
K930014PROCLINIC ONE-STEP DIPSTICK PREGNANCY TESTVanguard Biomedical Corp.1993-03-25800
K914254HOMECLINIC ONE STEP PREGNANCY TESTVanguard Biomedical Corp.1991-10-17240
K914253PROCLINIC ONE STEP PREGNANCY TESTVanguard Biomedical Corp.1991-10-11180
K910351MINICLINIC OVULATION PREDICTION TESTVanguard Biomedical Corp.1991-03-21650
K895560MODIFIED HOMECLINIC PREGNANCY TESTVanguard Biomedical Corp.1989-11-13680
K894012MINICLINIC PREGNANCY TESTVanguard Biomedical Corp.1989-07-25490
K891762MINICLINIC OVULATION PREDICTION TESTVanguard Biomedical Corp.1989-07-201180
K883826HOME CLINIC PREGNANCY TESTVanguard Biomedical Corp.1988-11-29810

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda